(74 days)
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML technology.
No.
The device's intended use is for protection and prevention of microorganism, body fluid, and particulate transfer, not for treating any medical condition or disease.
No
Explanation: The device is a medical/surgical mask, which serves as a protective barrier to prevent the transfer of microorganisms, body fluids, and particulate aerosols. Its purpose is protective, not diagnostic.
No
The device description clearly outlines physical components like layers of material, ear loops, and a nose piece, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to act as a physical barrier to prevent the transfer of microorganisms, body fluids, and particulate aerosols between healthcare workers, patients, and the environment during medical and surgical procedures. This is a physical barrier function, not a diagnostic one.
- Device Description: The description details the physical construction of the mask (layers, materials, ear loops, nose piece). There is no mention of reagents, assays, or any components designed to analyze biological samples.
- Performance Studies: The performance studies focus on the physical barrier properties of the mask (fluid resistance, filtration efficiency, breathability, flammability). These are relevant to a protective barrier device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Dukal medical / surgical masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid and particulate aerosol transfer.
Product codes
FXX
Device Description
Dukal Surgical Masks are pleated 3 – ply masks. Inner and outer layers are made of either medical grade tissue or 100% spun-bond polypropylene. Middle layer is made of 100% melt blown polypropylene filter. Ear loops are made of soft latex free elastic loops. The nose piece for all Dukal Masks is a malleable aluminum wire. Masks with splash visors have an anti fog treated plastic shield attached to masks. All of the material used in the construction of the Dukal face masks are being used in currently marketed devices (see predicate information)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare workers and patients involved in medical and surgical procedures.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics:
- Fluid Resistance Performance (mmHg): ASTM F1862-05 Pressure at 80mm Hg. Dukal: 30 out of 32 passed. Medicom K051291: 19 out of 32 passed.
- Particulate Filtration Efficiency Performance (%): ASTM2299. Dukal: 98.3%. Medicom K051291: 98.7%.
- Bacterial Filtration Efficiency Performance (%): ASTM F2101-01 ASTM F2100-04. Dukal: 99.9%. Medicom K051291: 99.8%.
- Differential Pressure (Delta-P) (mmH2O/cm2): ASTM F2101-01 MIL-M-36945C 4.4.1.1.1 Method 1. Dukal: 2.28 (ave) mmH2O/cm². Medicom K051291: 2.28 (ave) mmH2O/cm².
- Flammability class 1: ASTM F2101-01 MIL-M-36945C 4.4.1.1.1 Method 1. Dukal: No Flame Spread Class 1. Medicom K051291: No Flame Spread Class 1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
510(k) Summary
SEP 1 8 2006
Device Trade Name: Non Sterile Surgical Mask
Name and Address of Manufacturer: Dukal Corporation 5 Plant Ave Hauppauge, NY 11788
Establishment Registration: 2435946
Contact Person: Patrick J. Lamb Vice President International Operations 5 Plant Ave. Hauppauge, NY 11788
Device Classification Name: Mask, Surgical
Classification Panel: Class II, §878.4040
Classification Advisory Committee: General and Plastic Surgery
Product Code: FXX
Recognized Performance Standard:
ASTM 2100-04 Refer to submission for applicable standards
Predicate Devices
- 510(k) Number 1. A.R. Medicom K051291
- ValuMax International (K040333
1
.
| Intended Use: | The Dukal medical / surgical masks are indicated as a
protective nose and mouth covering for healthcare workers
and patients involved in medical and surgical procedures.
The masks are indicated in any procedure or situation
where there is a risk of microorganism, body fluid and
particulate aerosol transfer. |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Statement: | A 510(k) statement for this device, as required by 21 CFR 93, is
replaced with this 510(k) summary. |
| Truthful and Accurate
Statement: | A Truthful and accurate statement as required by 21 CFR
§807.87(j) may be found in the submission in Exhibit A |
| Labeling: | Samples of proposed labeling may be found in the submission in
Exhibit B |
| Device Description: | Dukal Surgical Masks are pleated 3 – ply masks. Inner and
outer layers are made of either medical grade tissue or
100% spun-bond polypropylene. Middle layer is made of
100% melt blown polypropylene filter. Ear loops
are made of soft latex free elastic loops. The nose piece for
all Dukal Masks is a malleable aluminum wire. Masks with splash
visors have an anti fog treated plastic shield attached to masks. All
of the material used in the construction of the Dukal face
masks are being used in currently marketed devices (see
predicate information) |
:
2
ッ
: : :
| Item | Test Method | Dukal | Medicom K051291 |
|---|---|---|---|
| Inner Layer | Raw material | ||
| Specifications | 100% Spun-bond | ||
| polypropylene | |||
| or medical grade | |||
| tissue (25 gsm) | Same | ||
| Outer Layer | Raw material | ||
| Specifications | 100% Spun-bond | ||
| polypropylene or | |||
| medical grade | |||
| tissue (16gsm) | 100% Spun-bond | ||
| polypropylene or medical | |||
| grade tissue (14gsm) | |||
| Middle Layer | Raw material | ||
| Specifications | 100% melt blown | ||
| polypropylene | |||
| filter media | |||
| (25 gsm) | Same | ||
| Ear Loop | Raw material | ||
| Specifications | Soft latex free | ||
| elastic loops and | |||
| ties | |||
| (40 gsm) | Latex Free Elastic Loops | ||
| and ties | |||
| 38 gsm | |||
| Nose Piece | Raw material | ||
| Specifications | Malleable | ||
| aluminum wire | same | ||
| Plastic Shield | Raw material | ||
| Specifications | ATFF-High | ||
| Impact 0.10mm | same | ||
| Fluid | |||
| Resistance | |||
| Performance | |||
| (mmHg) | ASTM F1862-05 | ||
| Pressure at 80mm | |||
| Hg | 30 out of 32 | ||
| passed | 19 out of 32 passed | ||
| Particulate | |||
| Filtration | |||
| Efficiency | |||
| Performance | |||
| (%) | ASTM2299 | 98.3% | 98.7% |
| Bacterial | |||
| Filtration | |||
| Efficiency | |||
| Performance | |||
| (%) | ASTM F2101-01 | ||
| ASTM F2100-04 | 99.9% | 99.8% | |
| Item | Test | Dukal | Medicom K051291 |
| Differential Pressure | |||
| (Delta-P) | |||
| (mmH20/cm2) | ASTM F2101-01 | ||
| MIL-M-36945C | |||
| 4.4.1.1.1 Method 1 | 2.28 (ave) | ||
| mmH2O/cm² | 2.28 (ave) | ||
| mmH2O/cm² | |||
| Flammability class | |||
| 1 | ASTM F2101-01 | ||
| MIL-M-36945C | |||
| 4.4.1.1.1 Method 1 | No Flame Spread | ||
| Class 1 | No Flame Spread | ||
| Class 1 | |||
| Mask Styles | Tie, Ear Loop and | ||
| mask with fluid | |||
| shield | Tie, Ear Loop and | ||
| mask with fluid | |||
| shield | |||
| Color | Blue | Blue | |
| Layers | 3 | 3 | |
Performance Characteristics
.
3
.. . . .
: 上
Performace Characterics, con't
4
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 2006
Mr. Patrick J. Lamb Vice President International Operations Dukal Corporation 5 Plant Avenue Hauppauge, New York 11788
Re: K061864
Trade/Device Name: Dukal Surgical Face Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: August 18, 2006 Received: September 13, 2006
Dear Mr. Lamb:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
5
Page 2 - Mr. Lamb
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clara
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
्
510(k) Number (if